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Effect of rEPO in FGF23 in ESRD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803514
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Luis Toro, University of Chile

Brief Summary:

Objective: To evaluate the effects of recombinant Erythropoietin (rEPO) in plasma levels of Fibroblast Growth Factor 23 (FGF23) in End-Stage Renal Disease (ESRD) patients in hemodialysis.

Method: Prospective cohort of ESRD patients in HD, where patients with or without rEPO therapy were compared. Measurements of plasma FGF23 were performed at baseline and during the complete study. Demographic, clinical and laboratory data will be obtained.

Follow-up period: 12 weeks.


Condition or disease Intervention/treatment
Anemia Chronic Kidney Diseases Drug: Recombinant EPO

Detailed Description:

Experimental data has shown that recombinant erythropoietin (rEPO) increases plasma levels of Fibroblast Growth Factor 23 (FGF23) in murines, both health and with acute or chronic renal disease. Also, observational studies indicate an association between EPO and FGF23 levels in patients. Until now, it has not been demonstrated whether the use of rEPO does increase plasma FGF23 in End-Stage Renal Disease (ESRD) patients in hemodialysis (a population with a high use of this therapy for the management of chronic anemia).

Our objective was to evaluate whether the administration of rEPO increases plasma FGF23 levels in ESRD patients in hemodialysis.

We performed a prospective cohort with ESRD patients without rEPO therapy. We performed 2 groups: patients with requirements of rEPO therapy due to anemia (Hb < 10 g/dL) and patients without rEPO therapy (Hb > 10 g/dL).

We measured plasma FGF23 (intact and C-terminal) at baseline and during 12 weeks.

Demographic, clinical and laboratory data was obtained. Patients treated with rEPO received beta-epoetin (Recormon, Roche), according to current recommendations.

Patients were follow-up during 3 months to evaluate the effects of rEPO. Our primary outcome was changes in plasma intact FGF23 at 12 weeks, between both groups.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Recombinant Erythropoietin in Plasma Levels of FGF23 in End-Stage Renal Disease Patients
Actual Study Start Date : August 15, 2017
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : October 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort Intervention/treatment
Treated group (rEPO)

Patients with ESRD in HD, and medical indication of recombinant EPO for management of anemia (Hb < 10 g/dL). Ambulatory hemodialysis 3 times per week.

Recombinant beta-epoetin (Recormon) will be used, according to current recommendations.

Clinical and laboratory data will be obtained before and during the study. The primary outcome (changes of plasma intact FGF23) will be measured during the follow-up, up to 12 weeks.

Drug: Recombinant EPO
Beta-epoetin (Recormon, Roche). Dosage was performed according to current recommendations.
Other Name: rEPO

Control group

Patients with ESRD and HD, without medical indication of recombinant EPO (Hb > 10 g/dL). Ambulatory hemodialysis 3 times per week.

Follow-up for 3 months, similar than rEPO group. Clinical and laboratory data will be obtained before and during the study, similar periods than rEPO group.

The primary outcome (changes of plasma FGF23) will be measured every 2 week during the evaluation period.




Primary Outcome Measures :
  1. Changes in plasma intact FGF23 levels [ Time Frame: 12 weeks ]
    Measurements of plasma intact FGF23 levels


Secondary Outcome Measures :
  1. Changes in plasma C-terminal FGF23 levels [ Time Frame: 12 weeks ]
    Measurements of plasma C-terminal FGF23 levels

  2. Changes in hematocrit and hemoglobin [ Time Frame: 12 weeks ]
    Measurements of hematocrit and hemoglobin in blood samples

  3. Changes in parathormone levels [ Time Frame: 12 weeks ]
    Measurements of parathormone levels in blood samples


Biospecimen Retention:   Samples Without DNA
Plasma samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pacients in chronic hemodialysis, will be measured with FGF23 levels
Criteria

Inclusion Criteria:

  • End-Stage Renal Disease
  • Requirements of Hemodialysis
  • At least 6 months since initiation of hemodialysis

Exclusion Criteria:

  • Pregnancy
  • Treatment with rhEPO or analogs during the previous 6 months or earlier

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803514


Locations
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Chile
Hospital Clinico Universidad de Chile
Santiago, Chile
Sponsors and Collaborators
University of Chile
Investigators
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Study Chair: Luis Michea, MD PhD University of Chile
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Responsible Party: Luis Toro, Co-researcher, University of Chile
ClinicalTrials.gov Identifier: NCT03803514    
Other Study ID Numbers: ID-11102-23
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics